Croscarmellose sodium NEW

Specification of Croscarmellose sodium CAS 74811-65-7:

Welcome to inquire us to get the complete COA

Croscarmellose Sodium is a modified form of cellulose (a natural polymer derived from plant fibers) that is widely used in the pharmaceutical industry as a superdisintegrant.

It is not an active drug but a critical pharmaceutical excipient—an inactive substance that serves as a vital component of a drug's formulation to ensure it works as intended.

Primary Function: The Tablet Disintegrant

The primary and most important job of Croscarmellose Sodium is to make tablets break apart quickly and efficiently in the digestive tract.

Imagine swallowing a tablet. For the active drug to be absorbed into your bloodstream, it must first be dissolved in the gastrointestinal fluids. If the tablet simply dissolved from the outside in, it would be a very slow process. This is where the disintegrant comes in.

Here's how Croscarmellose Sodium works:

1. Rapid Water Uptake (Wicking): Croscarmellose Sodium is highly hygroscopic, meaning it has a very strong ability to draw water into the tablet.

2. Swelling: Once it absorbs water, it swells to several times its original volume.

3. Breaking Apart: This rapid and significant swelling creates immense internal pressure and physical force within the tablet's matrix, literally pushing the compressed powder particles apart. This process breaks the tablet down into smaller granules, a process known as disintegration.

4. Increased Surface Area: By breaking the tablet into fine particles, it dramatically increases the surface area exposed to digestive fluids.

5. Faster Dissolution and Absorption: With more surface area available, the active drug can dissolve much more quickly, leading to faster absorption and a quicker onset of action.

This entire process typically happens within minutes.

Key Properties and Advantages

• "Super" Disintegrant: It is much more effective at lower concentrations (typically 0.5% - 5% of the tablet weight) than traditional disintegrants like starch.

  Mechanism: It acts primarily through swelling, with little tendency to form gels, which means it works effectively even under low compression force and in various pH environments found in the gut.

  Insolubility: It does not dissolve in water, which allows it to remain intact and perform its swelling action effectively.

  Compatibility: It is generally chemically inert and does not interact with most active pharmaceutical ingredients (APIs).

Common Uses and Applications

Croscarmellose Sodium is one of the most common excipients found in solid oral dosage forms. You will find it in:

• Tablets: This is its primary use, in both immediate-release and fast-dissolving tablets.

  Capsules: It can be used in the powder fill of hard gelatin capsules to ensure the contents break apart and disperse quickly once the capsule shell dissolves.

  Orally Disintegrating Tablets (ODTs): It is crucial for formulations that are designed to disintegrate in the mouth within seconds, without the need for water.

Essentially, if you have ever taken a pill that quickly broke apart after swallowing, it almost certainly contained a disintegrant like Croscarmellose Sodium.

Safety and Regulatory Status

• Safety: It is considered non-toxic, non-irritating, and non-allergenic. It is not absorbed by the body; it passes through the digestive system unchanged and is excreted.

  Regulatory Approval: It is approved for use in pharmaceutical products by all major regulatory agencies worldwide, including the U.S. FDA, the European Medicines Agency (EMA), and others.

  Common Names: You might see it listed on medication labels under "inactive ingredients" as Croscarmellose Sodium, Sodium Croscarmellose, or sometimes by its brand name, Ac-Di-Sol®.

Key Takeaways

• Identity: A modified, cross-linked polymer derived from cellulose.

  Primary Role: A superdisintegrant used in tablets and capsules.

  Mechanism: Works by rapidly absorbing water and swelling, which physically breaks the tablet apart.

  Benefit: Ensures fast disintegration, leading to rapid drug dissolution and quicker onset of therapeutic effect.

  Safety: Inert, non-absorbed, and universally approved as a safe excipient.

Disclaimer: This information is for educational purposes only. For specific questions about the ingredients in your medication, always consult with a pharmacist or healthcare provider.

Package of Croscarmellose sodium CAS 74811-65-7:

Application of Croscarmellose sodium CAS 74811-65-7:

Pharmaceutic aid, used as Disintegrant in Capsules, Tablet and Granule Formulations.